All SAEs including death should be reported: CDSCO Panel tells AstraZeneca about Durvalumab
New Delhi: Granting the protocol amendment proposal presented by drug major AstraZeneca for anticancer drug Durvalumab, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has stated that all serious adverse events (SAEs) including death irrespective of its cause should be reported to CDSCO as per provision of New Drugs and Clinical Trials Rules (NDCT Rules) 2019 by the principal investigator (PI) and Sponsor.
This came after the applicant presented protocol amendment version 2.0 (amendment 1) dated 02-08-2022 before the committee.
Durvalumab injection is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells.
Durvalumab blocks the interaction of PD-L1 with PD-1 and CD80 (B7. 1) to release the inhibition of immune responses, without inducing antibody-dependent cell-mediated cytotoxicity
Durvalumab is used alone to treat non-small cell lung cancer (NSCLC) that spread to nearby tissues and cannot be removed by surgery but has not worsened after being treated with other chemotherapy medications and radiation treatments. It is also used in combination with tremelimumab-actl (Imjudo) and platinum-based chemotherapy to treat a certain type of NSCLC that has spread throughout the lungs and to other parts of the body.
At the recent SEC meeting for Oncology and Hematology held on 14th March 2023, the expert panel reviewed the proposal presented by the drug major AstraZeneca for the protocol amendment in the Phase III clinical trial of the anticancer drug Durvalumab.
After detailed deliberation, the committee recommended the approval of the proposed protocol amendment with the condition that all SAEs including death irrespective of its cause (death due to PD) should be reported to CDSCO as per the provision of NDCT Rules 2019 by the PI & Sponsor.
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